# K964139: Sysmex CA-6000

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Feb 6, 1997 after 114 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894052 (1989). 1 ancestor in all.
7 later devices descend from it; 6 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894052: Electra 1000C Automatic Coagulation Timer, Medical Laboratory Automation Systems, Inc. (1989) Summary page 1.

## Most influential descendants
- K020979: Sysmex Automated Coagulation Analyzer, Model #CA-7000 (2002), 1 descendant of its own
- K993299: Sysmex Automated Coagulation Analyzer, Model CA-1500 (1999), 1 descendant of its own
- K162420: Sysmex Automated Blood Coagulation Analyzer CS-5100 (2016), 0 descendants of its own
- K031377: Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and -560 (2003), 0 descendants of its own
- K011665: BCT System (2001), 0 descendants of its own

## Indications for use
Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer.

Source page: https://510kreport.com/device/K964139
Methodology: https://510kreport.com/methodology